Patient-Reported Data Tracking for Cancer

Overseen By Erin Laurie-Zehr, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: No email, No smartphone, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

240 Participants Needed

Trial Summary

What is the purpose of this trial?

This study assesses the feasibility and acceptability of a brief electronic patient-reported outcome (ePRO) tool that allows patients to self-identify impending delays. The risk of treatment delays according to tumor type and race will be measured by both ePRO and electronic health record (EHR) tools. Data from this study and the association of social determinants of health could be useful to flag patients at risk of delay and due timely intervention for modifiable treatment barriers. The prediction of the risk of treatment delay will be helpful to design another study using electronic tracking systems to prevent cancer treatment delays. The long-term goal of this research is to alert care teams when patients may be at risk of treatment days and to help patients get treatment faster. It was planned to enroll a total of 240 subjects with newly diagnosed cancer. Sixty colorectal and 180 breast cancer patients will be included.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Weekly Survey for cancer?

Research suggests that using patient-reported data, like weekly surveys, can improve the care process in cancer treatment by helping detect symptoms early and facilitating timely interventions, although it may not directly improve patient outcomes like quality of life. ^{1 2 3 4 5}

Is the patient-reported data tracking for cancer treatment safe for humans?

The patient-reported data tracking system, known as PRO-CTCAE, is designed to improve the reporting of side effects during cancer treatment. It has been positively received by stakeholders for its potential to enhance the accuracy and completeness of symptom data, which can help in making better treatment decisions and improving patient safety. ^{6 7 8 9 10}

How does this treatment differ from other cancer treatments?

This treatment is unique because it involves real-time tracking of patient-reported outcomes (PROs) using familiar technology like social media apps and smartphones, which helps patients manage symptoms better and communicate more effectively with clinicians. Unlike traditional methods that rely on retrospective data, this approach provides immediate feedback and enhances patient engagement in their own care. ^{11 12 13 14 15}

Research Team

Katie Reeder-Hayes

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults over 18 with a recent diagnosis of breast or colorectal cancer who plan to receive treatment at the University of North Carolina. They must be able to get and respond to surveys electronically and give consent. Those without email or smartphone access, unable to consent, or not fluent in English cannot join.

Inclusion Criteria

I am over 18 years old.

I have not started any cancer treatment yet.

I was diagnosed with breast or colorectal cancer in the last 6 weeks.

Exclusion Criteria

Patient cannot read and speak English

I am unable or unwilling to receive and complete surveys electronically.

Patient unwilling or unable to provide verbal or signed consent to participate

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Participants complete weekly electronic patient-reported outcome (ePRO) questionnaires to identify treatment delays

8 weeks

Weekly electronic surveys

Follow-up

Participants are monitored for treatment initiation and delays using ePRO and EHR tools

8 weeks

Analysis and Reporting

Data from ePRO and EHR are analyzed to assess treatment delays and racial disparities

4 weeks

Treatment Details

Interventions

• Weekly Survey

Trial Overview The study tests an electronic tool where patients report issues that might delay their cancer treatment. It aims to identify if there's a link between race, social factors, and treatment delays using patient feedback and health records.

Participant Groups

Group I: electronic patient-reported outcome (ePRO) questionnaires. Experimental Treatment 1 Intervention

Subjects with colon or breast carcinoma will respond to weekly electronic patient-reported outcome (ePRO) questionnaires.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Findings from Research

Patient-reported data from 4,174 patients with lung or colorectal cancer indicated that a high percentage of patients met quality indicators for symptom screening (74% to 93%) and treatment (73% to 99%), suggesting that patients felt their symptoms were being adequately addressed.

In contrast, medical record data showed much lower percentages of patients meeting the same quality indicators (4% to 23%), highlighting the potential for patient-reported data to provide a more accurate and patient-centered view of the quality of supportive oncology care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the quality of supportive oncology using patient-reported data. Dy, SM., Walling, AM., Mack, JW., et al.[2022]

Patient-reported outcome measure (PROM) feedback interventions in oncology showed a positive impact on health-related quality of life (HRQL) and patient-healthcare provider communication, with a moderate effect size based on a meta-analysis of 29 studies involving 7071 cancer patients.

The intervention also demonstrated a significant improvement in 1-year overall survival rates, suggesting that providing feedback can enhance care processes and outcomes for cancer patients, although the findings are limited by a high risk of bias in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of routine provision of feedback from patient-reported outcome measurements for cancer care improvement: a systematic review and meta-analysis. Lu, SC., Porter, I., Valderas, JM., et al.[2023]

The review of six studies found that while patient-reported outcome measures (PROMs) are used in cancer clinics, their impact on improving patient outcomes like quality of life and satisfaction is limited, indicating a need for better implementation strategies.

Future interventions should focus on training healthcare professionals to effectively use PROM data, enhancing patient self-efficacy, and ensuring that PROMs are specific and interpretable, while future trials should adopt cluster-randomized designs to better control for contamination and link PROM use to patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient outcomes through the routine use of patient-reported data in cancer clinics: future directions. Luckett, T., Butow, PN., King, MT.[2022]

In a study of 484 colorectal cancer patients, 61% opted to receive individual feedback reports on their patient-reported outcomes, which 92% found useful.

Patients who received feedback had a higher response rate to follow-up questionnaires, indicating that such reports may enhance patient engagement and retention in studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an individual feedback report on patient-reported outcomes in the Prospective Dutch ColoRectal Cancer cohort. Vissers, PAJ., Vink, GR., Koelink, MR., et al.[2022]

Patient-reported outcomes (PROs) are increasingly important in randomized clinical trials for cancer, as they provide insights into how patients experience treatments, which cannot be captured by clinician reports alone.

The commentary highlights nine clinical trials where PROs significantly contributed to understanding treatment effects, demonstrating their value in guiding clinical practice, informing patients, and aiding health policy decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Listening to the Patient Voice Adds Value to Cancer Clinical Trials. Brundage, MD., Crossnohere, NL., O'Donnell, J., et al.[2023]

A survey of 727 stakeholders in cancer clinical research revealed that 93% believe patient-reported outcomes (PROs) for adverse events would enhance understanding of patient experiences during treatment.

The majority of respondents (88%) felt that using the PRO-CTCAE would improve the quality and efficiency of symptom data collection, indicating strong support for its implementation in clinical trials to inform treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Bruner, DW., Hanisch, LJ., Reeve, BB., et al.[2022]

The study involved 127 cancer patients undergoing chemotherapy or radiation therapy, and it confirmed that most adverse event (AE) terms in the PRO-CTCAE library were easily understood by patients, regardless of their education level.

Minor modifications were made to 17 AE terms to enhance clarity and comprehension, ultimately supporting the content validity of the PRO-CTCAE for accurately capturing patient-reported outcomes during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Hay, JL., Atkinson, TM., Reeve, BB., et al.[2022]

In a study involving 37 men with metastatic prostate cancer, patient-reported symptoms using the QLQ-C30 questionnaire identified 55 symptoms that physicians did not report, highlighting a significant gap in symptom detection by clinicians.

Physician reporting of chemotherapy side effects showed low sensitivity (47%) and specificity (68%) compared to patient reports, indicating that relying solely on clinician assessments may overlook important adverse events experienced by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. Fromme, EK., Eilers, KM., Mori, M., et al.[2022]

The study aims to evaluate a smartphone application designed for real-time reporting of adverse events in cancer treatments, which could enhance early detection and management of side effects, ultimately improving patient safety and treatment outcomes.

The trial will involve 66 patients over six months, assessing the feasibility of the app and comparing the quality of life and therapy doses between those using the app and those receiving standard care, highlighting the importance of patient-reported symptoms in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. Kestler, AMR., Kühlwein, SD., Kraus, JM., et al.[2021]

Direct patient reporting of adverse events in cancer treatment through electronic interfaces may improve the accuracy and completeness of symptom reporting, addressing the issue of underreporting by clinical staff.

The National Cancer Institute is developing and testing a new system called the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, which aims to enhance the collection of adverse symptom information from patients in clinical research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic toxicity monitoring and patient-reported outcomes. Basch, EM., Reeve, BB., Mitchell, SA., et al.[2022]

A study involving 262 cancer patients in Japan found that 60% consented to participate in a touch screen tablet survey, with a completion rate of 58%, indicating a generally positive response to this method of data collection.

The majority of patients (92%) found the touch screen survey easy to use, and 95% felt comfortable answering the questions, although older patients were more likely to require assistance, suggesting that this method may need adjustments for certain demographics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a Touch Screen Tablet Psychosocial Survey Administered to Radiation Therapy Patients in Japan. Suzuki, E., Mackenzie, L., Sanson-Fisher, R., et al.[2018]

A feasibility study involving 73 breast cancer patients demonstrated that using the LINE app for daily patient-reported outcomes (PROs) led to a high response rate of 95.5%, with an average of 224.9 reports per patient over a median observation period of 435 days.

The system's design, utilizing a popular social media application rather than a specialized tool, contributed to its acceptance across all age groups, including older patients, indicating that familiar technology can enhance patient engagement in reporting symptoms during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility study on collecting patient-reported outcomes from breast cancer patients using the LINE-ePRO system. Hayashida, T., Nagayama, A., Seki, T., et al.[2022]

A study involving 60 patients and 50 providers revealed that bar charts and line graphs are preferred over pictographs for displaying patient-reported outcomes (PROs) related to health-related quality of life (HRQOL) after prostate cancer treatment.

Pilot testing of personalized PRO dashboards with 12 patients showed improved compliance with quality indicators for prostate cancer care, indicating that these dashboards can effectively integrate patient-generated data into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and feasibility of integrating personalized PRO dashboards into prostate cancer care. Hartzler, AL., Izard, JP., Dalkin, BL., et al.[2018]

Using patients' own smartphones to monitor quality of life (QoL) indicators in cancer clinical trials could significantly reduce the resources and personnel needed for continuous monitoring.

A pilot study demonstrated that the Human Dynamics Reporting Service (HDRS) app can effectively track physical, psychological, social, and environmental aspects of patients' lives, linking them to standardized QoL measures like the EORTC QLQ-C30.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone Sensors for Monitoring Cancer-Related Quality of Life: App Design, EORTC QLQ-C30 Mapping and Feasibility Study in Healthy Subjects. Asensio-Cuesta, S., Sánchez-García, Á., Conejero, JA., et al.[2023]

A study involving 25 women with breast cancer revealed that using a real-time tracking tool improved the consistency of symptom tracking compared to traditional methods, which were often fragmented.

Participants reported that the tracking tool helped them identify patterns in their symptoms, provided psychosocial comfort, and enhanced their communication with healthcare providers, suggesting it could lead to better symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probing the benefits of real-time tracking during cancer care. Patel, RA., Klasnja, P., Hartzler, A., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluating the quality of supportive oncology using patient-reported data. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of routine provision of feedback from patient-reported outcome measurements for cancer care improvement: a systematic review and meta-analysis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Improving patient outcomes through the routine use of patient-reported data in cancer clinics: future directions. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of an individual feedback report on patient-reported outcomes in the Prospective Dutch ColoRectal Cancer cohort. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Listening to the Patient Voice Adds Value to Cancer Clinical Trials. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). [2022]

8. United States pubmed.ncbi.nlm.nih.gov

How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Electronic toxicity monitoring and patient-reported outcomes. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Acceptability of a Touch Screen Tablet Psychosocial Survey Administered to Radiation Therapy Patients in Japan. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Feasibility study on collecting patient-reported outcomes from breast cancer patients using the LINE-ePRO system. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Design and feasibility of integrating personalized PRO dashboards into prostate cancer care. [2018]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Smartphone Sensors for Monitoring Cancer-Related Quality of Life: App Design, EORTC QLQ-C30 Mapping and Feasibility Study in Healthy Subjects. [2023]

15. United States pubmed.ncbi.nlm.nih.gov

Probing the benefits of real-time tracking during cancer care. [2022]